The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.

Safety assessments by laboratory testing and physical exams will be conducted through-out the study.

Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.

Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

nab-Paclitaxel 125 mg/m2 intravenous (IV) infusion over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle Subjects who complete 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator will then determine the best option for the subject.

Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR

Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR

Time to Treatment Failure [ Time Frame: up to 1 year from the time the last patient first treatment ]

Time after the first dose of study therapy to treatment failure

Secondary Outcome Measures :

Disease Control Rate [ Time Frame: up to 6 months from last patient first treatment ]

the combined incidence of complete response, partial response and stable disease measured at the End of Treatment visit

Overall Response Rate [ Time Frame: up to 6 months from last patient first treatment ]

the combined incidence of CR and PR

Progression-free Survival [ Time Frame: up to 1 year from last patient last treatment ]

the time after the first dose of study therapy to disease progression or death (by any cause)"

Overall Survival [ Time Frame: up to last patient last visit ]

the time after the first dose of study therapy to death by any cause

Composite Health-related Quality of Life [ Time Frame: up to last patient last treatment ]

Differences in outcomes from baseline, during treatment, and after treatment for the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQs), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30) and Quality of Life Questionnaires (QLQ-PAN26).

Number of Adverse Events [ Time Frame: up to 28 days from last patient last visit ]

After signing Informed Consent Form (ICF) and until 28 days after the last dose of Investigational Product (IP) or 28-day Follow up Visit, whichever occurs later. Not during survival unless it is a suspected SAE.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

•≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function

Signed informed Consent

Exclusion Criteria:

Active bacterial, viral, or fungal infection

Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive

Subjects with sensory neuropathy, ascites, or plastic biliary stent.

Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)